Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'

Summary

Participation Requirements

Description

There will be an open-label two arm clinical trial with participants randomised to Biktarvy or Symtuza with equal probability. Study treatment will last for 48 weeks. Baseline - Following confirmatory HIV testing potential participants will have a appointment with a study doctor. Full medical check ...

There will be an open-label two arm clinical trial with participants randomised to Biktarvy or Symtuza with equal probability. Study treatment will last for 48 weeks. Baseline - Following confirmatory HIV testing potential participants will have a appointment with a study doctor. Full medical check and medical history undertaken. Patients will be offered opportunity to participate in the study. To avoid unnecessary visits and in line with the study aim of getting patients on treatment rapidly patients can consent on the same day that HIV diagnosis is confirmed to them. Treatment to be initiated following appointment in line with test and treat procedure. Samples will be taken (if not available from previous days) for all initial required tests. Participants will be given baseline questionnaires that they can return on week 2 visit. Week 1 call - Call to check drug adherence, adverse events and patient wellbeing. Week 2 visit - Appointment with study doctor to review all results from initial tests. Following undertaken: viral load? vital signs? adverse events? adherence assessment. Week 4, 12, 24, 48 Follow-up visits - Full medical review undertaken at each visit including safety blood tests. Following undertaken: viral load? adverse events? adherence assessment? questionnaires? samples taken for secondary and exploratory objectives. Week 48 visit will be the end of study treatment period. Follow-up visit - up to 30 days after the week 48 visit there will be a follow-up visit to complete final medical assessment and final adverse events reporting. Samples will be collected from participants further to those required for stated objectives to be retained for future research into HIV infection. We will also collect and clinical data cohort of data on all patients newly diagnosed with HIV during a set window. Clinical data will be collected from their first year after diagnosis.

Tracking Information